Status:
COMPLETED
Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) With Tadalafil Daily
Lead Sponsor:
Eli Lilly and Company
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
45+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary freq...
Eligibility Criteria
Inclusion
- Men 45 years of age or older with Benign Prostatic Hyperplasia (BPH) also referred to as BPH-LUTS \[lower urinary tract symptoms\] based on the disease diagnostic criteria at the start of study.
- Provide signed informed consent at the start of the study.
- Have not taken Finasteride therapy for at least 3 months before study drug is dispensed and Dutasteride therapy for at least 6 months before study drug is dispensed.
- Have not taken other BPH therapy (including herbal preparations), overactive bladder (OAB) therapy, or erectile dysfunction (ED) therapy for at least 4 weeks prior to study drug is dispensed.
- Agree not to use any other approved or experimental pharmacologic BPH, OAB, or ED treatments anytime during the study
- Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 when study drug is dispensed.
- Have reduced peak urine flow rate when study drug is dispensed (measured by a special toilet equipment).
- Demonstrate compliance with study drug administration requirements.
Exclusion
- Treated with nitrates for a cardiac conditions.
- Have unstable angina or angina that requires treatment.
- Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
- Have very high or very low blood pressure
- Have problems with kidneys, liver, or nervous system.
- Have uncontrolled diabetes.
- Have had a stroke or a significant injury to brain or spinal cord.
- Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer (Prostate-Specific Antigen \[PSA\] greater than 10 nanograms/milliliter \[ng/ml\] at the start of study).
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT00827242
Start Date
January 1 2009
End Date
November 1 2009
Last Update
November 17 2010
Active Locations (27)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Huntsville, Alabama, United States, 35801
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Middlebury, Connecticut, United States, 06762
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sarasota, Florida, United States, 34237
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Roswell, Georgia, United States, 30076